Extended-release hydrocodone launched

A new extended-release tablet with hydrocodone was launched in the United States at the end of January.

Purdue Pharma said Hysingla™ ER (hydrocodone bitartrate) extended-release tablets CII is a once-daily, single-entity medication created with the company's proprietary extended-release solid oral platform, RESISTEC™. That means the medication has “abuse-deterrent properties that are expected to deter misuse and abuse via chewing, snorting and injection.”

“It's a sign that opioids with abuse-deterrent properties are being embraced by the healthcare community,” said Mark Timney, CEO of Purdue Pharma.

Hysingla ER does not contain acetaminophen, which can lead to acute liver failure.

“Acetaminophen toxicity and the misuse and abuse of opioids are real concerns among clinicians treating people with chronic pain,” said Bob Twillman, Ph.D., executive director of the American Academy of Pain Management. “The availability of a hydrocodone product with abuse-deterrent properties that does not contain acetaminophen gives healthcare professionals and chronic pain patients an important new option.”

Prescription opioid abuse sends more than 400,000 people to emergency rooms annually, according to the Centers for Disease Control and Prevention. The medications cause 71% of the deaths relating to pharmaceutical overdose, and the Food and Drug Administration has increasingly been trying to find strong painkillers that also are difficult to abuse.

In 2013, the agency approved updated labeling for Purdue Pharma L.P.'s reformulated OxyContin tablets to indicate the product has properties that make abuse difficult via injection or intranasally. In October, the FDA approved Pfizer's Embeda.

Hysingla, approved by the FDA in November, is offered in 20 mg, 30 mg, 40 mg, 60 mg, 80 mg, 100 mg and 120 mg. The tablets are difficult to crush or mix with water, although critics say addicts will likely find a way.

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